The Lachman Blog

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21
Jul

Orphan Drug Designations Skyrocket

Orphan Drug Designations (ODD) at the FDA has soared over the past few years with yearly jumps of 30% not uncommon.  In a blog posted today on FDA’s website, Dr. Gayatri Rao, Director for the Office of Orphan Products Development (OOPD) notes that: “In 2014, we saw a 30% increase over the prior year’s record […]

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14
Jul

Tolling of Forfeiture – A Hint of FDA’s Thinking

Ever since the forfeiture provision related to 180-day exclusivity as it relates to the requirement that firms receive approval or tentative approval within 30 months from receipt of an ANDA, there has been some industry confusion regarding the exception of a “change in requirements” and how that might toll the 30-month provision.  Kurt Karst provides […]

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13
Jul

FDA SUPPORTS SHARING FEEDBACK ON INVESTIGATOR CONDUCT DURING INSPECTIONS

If you work in regulated industry, you will eventually be inspected by the Food and Drug Administration (FDA).  With each inspection comes an opportunity to forge good working relationships with the individuals on the forefront of your compliance status.  With so much riding on any given inspection, what do you do if problems arise with […]

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10
Jul
Draft Guidance on Changes to ANDA Labeling Where the RLD Has Been Removed from the Market Image

Draft Guidance on Changes to ANDA Labeling Where the RLD Has Been Removed from the Market

FDA issued a draft Guidance titled “Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn” (here)  describing how and what type of changes FDA anticipates ANDA applicants to make in such situations. FDA makes clear in the Guidance that it the Guidance does not have applicability to the FDA’s […]

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08
Jul

Additional Guidance for Compounders of Commercially Available Copies of Products

Yesterday, FDA issued two draft Guidance documents that address the compounding of essentially commercially available drug products.  The two documents, one for compounding pharmacies under Section 503A of the Act (here) and the other that addresses outsourcing facilities under Section 503B of the Act (here) describe FDA’s view of how the issue of compounding essentially […]

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